510(k) K882939— NIOBI-X RADIATION REDUCTION FILTER

Substantially Equivalent

American Canadian Products, Inc.

Clearance details

Applicant: American Canadian Products, Inc.
Product code: Code ITY
Advisory panel: Radiology
Date received: 1988-07-13
Decision date: 1988-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

Adverse events under product code ITY

product code ITY

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.